Sample Receipt & Report Dispatch Unit
  1. SRRD has been functional as an independent unit since 2008. It is one of the important functionaries of the institute. The Unit is main interface between NIB and its stakeholders for all the products that are received in the institute. Biologicals samples of various categories for QC testing are forwarded to NIB from the Drug regulatory authorities of the country as part of mandatory submission of Performance evaluation report required as per regulatory guidelines. Besides, samples are also accepted from several government medical organizations (medical supplies), Drug Inspectors (survey and Legal samples).
    A. Sample submission requirements:

    I. Sample submission form 

     

    II. Essential Documents:

    a. Forwarding Letter from Drug Regulatory Authority or any other statutory authority of the country which has been marked to NIB for testing/evaluation purpose.

    b.  Copy of Import License/Test License issued by Govt. of India

    i.  Form -11 (Copy of Import License for Testing purpose)

    ii.  Form -10 (Copy of Import License for Commercial purpose)

    c.  Copy of Manufacturing License Issued by Govt. of India (In case of Indigenous Product) Form 25/28/29

    d.  Certificate of Analysis from Manufacturer in respect of the lot submitted for evaluation. 

    e. Batch Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin for the lot submitted for evaluation.

    f.  Three List of Country, where the drug is marketed or regulatory status of the drug in other countries.

    g. Summary of QC Protocols, Manufacturing Protocols from the manufacturer from country of origin/product information /brochure/leaflet (in original) in English language.

    h.  Pack insert and label Claim of the Product

     

    III.  Product Specific requirements: 

    a) Blood Products Lab- Plasma Based products: 

    1. Batch Release from the country of origin 

    2. Plasma pool certificated from NCL/manufacturer

    3. Source of Plasma 

    4. Period of collection of plasma 

    5. Certificate of compliance collection, processing storage and quality control of plasma as per WHO 6. List of countries product marketed

    7.  Method of viral inactivation 

    8. Certification of analysis with name of pharmacopoeia complied

     

    b)  Biochemical kit lab (Glucose strips) 

    1. Type of Sample: Blood Glucose Test strips designed for use with specific Glucometers as a closed system that reports the human blood glucose values in mg/dL units.

    2.  Condition of Packing: Blood Glucose Test Strips should be packed in properly labelled sealed containers that give the details of the manufacturer and/ or the importer and the Range of values reported by the strips for the Norma (Level I) and the Pathological (Level II) Control preparations.

    3.  Number of Samples Essential: 2400 Test Strips (1200 for the laboratory and 1200 as retained samples with the Sample Receipt unit) for testing one Batch by the Laboratory. 

    4. Accessories Required: 10 Glucometers designated for use with the Blood Glucose Test Strips as a closed system. 

    5. 3ml x 3 vials each of the manufacturers Normal/ Level I and Pathological/ Level II Glucose control Solution for testing one batch of Blood Glucose Test Strips.

     

    B. Testing fee requirements: 

    Testing Fee Details 

     Payment modes: 

    1. FOR PAYMENT/DEPOSIT OF TESTING FEE THOUGH BANK TRANSFER

     

    NAME OF BANK  :  BANK OF BARODA, SECTOR-29, NOIDA (U.P.) 

    NAME OF ACCOUNT  :  NATIONAL INSTITUTE OF BIOLOGICALS 

    S.B. ACCOUNT  :  26290100001774 

    IFSC CODE  :   BARB0NOIDAX 

    SWIFT CODE  :   2BARBINBBNOI

    MICR CODE NO.  :   110012066

    PAN -AAATN5228R 

    GSTIN -09AAATN5228R1ZX 

    ST No.-AAATN5228RST001 

    TIN -09466201769

     

    2. Net banking :  http://www.nib.gov.in/testing_fee.html

     

    Note:

     

    a) TESTING FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH SENT TO THE INSTITUTE FOR TESTING 

    b) Testing Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/ Port Offices of CDSCO which can be tested at NIB cannot be refunded. 

    c) Testing Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded or adjusted against other samples within a month of submission of testing fee. 

    d) Testing Fees submitted Online should also be intimated to the Institute through email (1) srrd@nib.gov.in (2) sksharma@nib.gov.in 

     

    C. Legal Sample Testing: Govt. analysts under schedule C1 as per the Gazette notification are notified for the below mention class of drugs.

    Govt_analyst.html

     

    D.  Online tracking of sample: 

    Samples are registered online via sample tracking software and upon receipt a registration id is created and communicated to sample sender (company) who can then monitor the status of the sample testing. 

    E. Documentation and Archiving: 

    All documents and records are kept in compliance to ISO: 17025. 

    F.Complete Unit is under CCTV Surveillance for necessary security and maintenance of samples and records. 

    G.Customer feedback is always acknowledged. Submission of feedback should be marked at srrd@nib.gov.in Further a Complaint Register has also being placed in the Unit for necessary redressal.

     

     

     

     

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013

 

Turnaround time for testing 

PROPOSED FOR COMMENTS :

 

 

   

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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